A cohort study assessing the feasibility of an RCT and acceptability and preliminary efficacy of a guided brief Mindfulness-Based Intervention for Sleep Disturbance in Dementia

Abstract

Objectives: Sleep disturbance (SDi) is common in people with dementia (PwD) and impairs cognitive, psychological and functional wellbeing. Pharmacological treatments have serious side-effects. There is a lack of non-pharmacological treatment guidance and provision. Guided brief Mindfulness-Based interventions (gbMBIs) are effective in alleviating SDi in adults and are pragmatic to deliver. This study primarily explored: 1) the feasibility of a randomised controlled trial (RCT) investigating the efficacy of a gbMBI in alleviating SDi in dementia; and 2) the acceptability of a gbMBI among dyads comprising the person with dementia and their caregiver. Secondarily, it assessed the preliminary efficacy of a gbMBI. Design: Uncontrolled cohort study; all dyads received the gbMBI. Method: Dyads (N=9) received Good Sleep Hygiene guidance (GSH) and PwD undertook a 1-week, nightly, 14-minute audio gbMBI. Quantitative data were used to assess feasibility of an RCT and mixed-method data for the acceptability and preliminary efficacy of the gbMBI. This study was exploratory and therefore no inferential analyses were performed. A modified mixed-method triangulation protocol unified mixed-method data. Results: Although research registers identified large pools of potential dyads, the eligibility rate did not exceed that of successful RCTs, whereas retention and adherence rates did. Triangulated data suggested the gbMBI delivery and content was acceptable to most, although some suggestions for improvement were recommended. Greater emphasis on GSH may increase acceptability. The gbMBI conflicted with the values of 2 dyads. Triangulated data provided some results suggesting alleviation of SDi and some that did not. Conclusions: An RCT may be feasible based on retention and adherence rates, but not eligibility rates; the gbMBI was acceptable among many dyads, but not all; the preliminary efficacy of the gbMBI was inconclusive. Overall, this study justified further development research into the efficacy of a gbMBI in treating SDi in dementia.